1. The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
2. The post-market surveillance obligations are complied with in accordance with Article 10(10);
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CHOI Younggwang
The technical documentation and the EU declaration of conformity are drawn up and kept up-to-date
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LEE Chang ho
1. The conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released
2. The post-market surveillance obligations are complied with in accordance with Article 10(10);
3. The reporting obligations referred to in Articles 87 to 91 are fulfilled